Professional Documents
Culture Documents
254]
Original Article
Abstract
Background: Although the symptomatology of Cuprum metallicum is quite vast, its other salts have fragmentary proving. Thus, homoeopathic
pathogenetic trial for Cuprum aceticum (Cu acet.) was taken up. Objective: To elicit the pathogenetic response to Cu acet. in homoeopathic
potencies on healthy human provers. Materials and Methods: A multi‑center, double‑blind randomized, placebo controlled, trial was conducted
at three centers of Central Council for Research in Homoeopathy. Proving was conducted on 50 relatively healthy provers selected after
conducting the Pretrial Medical Examination. All the provers were given placebo during the first phase of the trial. In the next two phases, Cu acet.
was administered in 6 C and 30 C potencies, in the intervention group (n = 34); and placebo in the placebo group (n = 16), after randomization.
The proving data so generated on Cu acet. were compiled and analyzed at the proving‑cum‑data processing cell. Results: Out of 34 provers
who were on actual drug trial, only 12 provers manifested symptoms. Twenty‑six and 20 symptoms were manifested in 6C and 30C potency,
respectively. Conclusion: The pathogenetic response elicited during the proving trial expands the scope of use of the homoeopathic medicine
C. aceticum. The symptoms generated in this trial will carry more value when verified clinically.
Keywords: Cuprum aceticum, Double blind, Drug proving, Homoeopathy, Pathogenetic effect, Placebo, Verdigris
How to cite this article: Mehra P, Mahajan A, Vichitra AK, Rajakumar BS,
DOI: Singh JP, Banoth K, et al. Homoeopathic pathogenetic trial of Cuprum
10.4103/ijrh.ijrh_54_20 aceticum: A multicentric, double-blind, randomized, placebo controlled
trial. Indian J Res Homoeopathy 2021;15:77-94.
Herrmann, and Ruckert, as well as various poisoning cases Inclusion and exclusion criteria
contributed by Dr. Hahnemann.”[3] Volunteers of both sexes with age more than 18 years, certified
Although the symptomatology of Cuprum metallicum is quite as healthy by the medical experts, found capable of carefully
vast in homoeopathic materia medica, its other salts have recording the facts, subjective, and objective symptoms
fragmentary provings. generated by the drug during proving and those who had not
taken any homoeopathic medicines in the last 2 months were
Homoeopathic drug proving is not only an integral part, but the included in the study.
first step to find out the pathogenetic effect of a drug substance.
Volunteers suffering from any acute or chronic disease,
Hence, this proving was conducted to assess the therapeutic
color blindness, anxiety or hysteria, having any addictions,
effect of Cu acet.
undergoing any kind of medical treatment, undergone surgery
Description in last 2 months, women during pregnancy, puerperium or
Details and chemical properties of cuprum acetate are as lactating, and those who had participated in another clinical
follows: or proving trial during the last 6 months were excluded from
the study.
Copper (II) acetate monohydrate (Cu [II] acetate) is odourless
and efflorescent. It is soluble in alcohol and slightly soluble in Sample size
ether and glycerol. Cu (II) acetate has many applications, as Sample size was determined as per the Drug Proving Protocol
a fungicide, insecticide, catalyst for organic reactions, as well of the Council,[6] according to which there should be at least
as applications in electrolysis and electroplating.[4] 15 provers at each center, 30% of whom shall act as control.
Therefore, 50 provers were enrolled at three centers for this
Cu (II) acetate is used in the biochemical applications such as
trial. 34 provers were under verum group and 16 were under
DNA extraction. Cu (II) complexes have been evaluated for
placebo group.
anticancer, antibacterial, and antifungal activities. These are
known to cleave DNA; however, increased efficiency is seen Randomization and blinding
in the presence of an oxidizer (often hydrogen peroxide).[5] Provers were randomized in two groups using stratified
randomization technique for each center, Group I: Homoeopathic
Materials and Methods medicine group and Group II: Placebo group. Random numbers
were generated with the help of computer‑based software
Study design and study setting available at www.randomizer.org,[7] and the random code
A multicenter prospective, randomized, double blind, placebo for the provers along with the information about the group
controlled study with allocation ratio of verum: placebo allocation was kept at CCRH headquarters. The decoding of
as 70:30 was conducted at three institutes of the Central the group was done after the compilation of the symptoms
Council for Research in Homoeopathy (CCRH): Dr. D. P. produced in both the groups.
Rastogi Central Research Institute of Homoeopathy, Noida,
Regional Research Institute of Homoeopathy, Gudivada Both homoeopathic drug and placebo were dispensed in
and Homoeopathic Drug Research Institute, Lucknow. identical form, visually indistinguishable from each other, from
Proving Master was Research Officer of the Council, having Nodal Office of Drug Proving Programme at Dr. D. P. Rastogi
post graduate degree in Homoeopathy whereas, Honorary Central Research Institute (Homoeopathy), Noida. Provers,
Consultants were the experts of various specialties of modern Proving Master and the Programme Officer were investigators
medicine engaged in the examination of volunteers/provers. and kept blinded to the group allocation and also to the identity
Medical experts constituted both of them. of the drug. All the provers were assigned code numbers and
coded drugs of different potencies were supplied in separate
Participants glass phials bearing code numbers of the respective prover.
Selection of provers
Intervention
Applications were invited from 15 to 20 volunteers
(from each center) of both sexes and age 18 years and above
Homoeopathic group
Homoeopathic dilutions of Cu acet. in 6C and 30C potencies
through a notice placed on the notice board of the institutes and
in 100 ml sealed bottles were procured from a Good
homoeopathic colleges. The volunteers of non-homoeopathic
Manufacturing Practices certified Homoeopathic Drug
background were also considered for the study. Pretrial medical
manufacturer, Hahnemann Publishing Company Private Ltd.,
examination (PME) was then conducted for 76 volunteers after
Kolkata, India. Globules of number 30 were medicated with
getting written informed consent from them, 05 of which were
these dilutions at the proving‑cum‑data processing cell at Nodal
from the non-homoeopathic background. Detailed physical,
office of Drug Proving.
pathological, and radiological examinations were conducted by
the medical experts to ensure the health status of the volunteers Placebo group
before enrolment into the study. For the pathogenetic drug trial Placebo consisted of nonmedicated globules (number 30)
of Cu acet, a total of 50 volunteers were enrolled as provers. moistened with nonmedicated dispensing alcohol (unsuccussed)
and was therefore indistinguishable from verum in appearance, as soon as they felt any change or any sign(s) and/or
taste, and color. symptoms(s) developed during the trial
• The provers noted down the sequence of the appearance
Duration of study of new sign(s) and/or symptoms(s), their progress and
Proving period: 1 year (2014–2015).
the number of doses after which such sign(s) and/or
Ethics and consent symptoms(s) appeared, with date, time of onset and
The Council’s 18th Ethical Committee approved the study duration for which they persisted
protocol on June 19, 2014. Proving Masters with experience • Any change in normal routine of the prover in respect of
in drug proving were sensitized about the protocol. Written daily habits pertaining to diet, living conditions etc., any
informed consent was received from all the volunteers prior to treatment taken was also noted in the Prover’s Day Book
enrolment in the study, after providing the detailed information Proforma.
about the trial. After disappearance of sign(s) and/or symptom(s) produced
All procedures were in accordance with the ethical standards by the drug, the volunteer had to wait for a further period
of the responsible committee on human experimentation and of 30 days (wash out period) before starting the next phase
with the Helsinki Declaration of 1975, as revised in 2013.[8] following the same dose schedule as stated above.
recommendation by a group of experts, Camphora 30C was and number of provers who developed symptoms during
used as an antidote. In case of prolonged or intensely disturbing the trial. The baseline information in both the groups was
symptoms, antidote was to be used by the Proving Master after comparable (P ≥ 0.05) and well matched as shown in Table 1.
consulting the medical expert.
Out of 50 enrolled provers, 42 provers underwent the TME. 06
Proving symptoms provers dropped out from the verum group while 02 provers
The sign(s) and/or symptom(s) generated by verum (drug) dropped out from placebo group. The descriptive data analysis
or control (placebo) on each prover are noted down for each was done for remaining 42 provers as per protocol.
phase, number of doses after which each of the signs or During the pathogenetic trial, out of 34 provers who were
symptoms appeared and the duration for which they persisted. in verum group, only 12 (35%) provers reported symptoms
The sign(s) and/or symptom(s) generated by verum group are consequent upon the administration of the drug. In the
separated from those generated by provers of control group. placebo group, five (31%) provers produced the symptoms.
The sign(s) and/or symptom(s) which were produced by the The symptoms developed after the administration of both
placebo in control and verum group provers are not taken into the potencies, i.e., 6C and 30C. Out of 46 symptoms which
consideration. were produced by the provers of verum group in the 2nd and
Statistical analysis 3rd phases, 26 symptoms were produced in 6C potency [Table 2]
The consolidated standards of reporting trials[9] and Red Hot while 20 symptoms were produced in 30C potency [Table 3].
guidelines[10] were adhered to report the outcome of the trial. In 6C potency, majority of symptoms developed after the
The compiled data of proving symptoms and the changes in the administration of 10–12 doses while in 30C potency symptoms
laboratory investigations were analysed using IBM Statistical developed after administration of 4–5 doses only.
Package for the Social Sciences (SPSS) version 20, USA for The following proving symptoms appeared in both 6C and
Windows was used for all the data analysis. 30C potency:
Comparisons between Homoeopathy and placebo groups were 1. Loquacity (talking about irrelevant things), did not want
performed at baseline to assess randomization effect using to be interrupted, if interrupted feels like hitting
independent “t‑test” for the continuous variable and “Chi‑square 2. Bursting pain in the frontal region of the head
test” for the categorical variables. Further “descriptive 3. Stitching pain in right lower molar
analysis” was done for the data with respect to the pathogenetic 4. Gripping, colicky pain in the abdomen
effect (signs and/or symptoms) produced during trial. 5. Dry cough
6. Stitching pain in lower extremities especially calf muscles
To distinguish placebo effect and nocebo effect, intra and inter 7. Fever.
prover analysis was done in both the groups.
Loquacity, stitching pain in right lower molar, stitching pain in
Pathogenetic effects lower extremities especially calf muscles and fever symptoms
Pathogenetic effects (Proving symptoms) are defined as all are reported by the same prover in both 6C and 30C potency.
changes in state of health and laboratory findings reported by They were reported singularly by different provers in the verum
the provers during the Homoeopathic Pathogenetic Trial and group only. They were not observed in the placebo group or
recorded in the final report. The incidence of pathogenetic the placebo phase of the verum group.
effects per prover is defined as the total number of findings
observed in verum group of the trial divided by the total Analysis was also done considering the physical built,
number of provers.[11] physical generals and mental generals of the provers in the
verum group who have produced symptoms but no significant
Pathogenetic effects were deduced from: similarities were found in these provers, which could have
i. Comparison of symptoms developed in the placebo phase been considered the constitutional symptoms. Further,
with symptoms during intervention phases (intra‑prover inter‑group analysis considering the above parameters were
comparison) done in the provers who have produced symptoms in the
ii. Comparison of symptoms developed by provers on
control (for all phases) with provers on actual drug
trial (inter‑prover comparison).
Results
From three drug proving centers where the study was
conducted, a total of 76 volunteers were screened and 50
apparently healthy volunteers were enrolled as provers.
Of 50 provers, 34 were on verum and 16 were on placebo.
Figure 1 shows the flowchart of the number of volunteers
who underwent screening, enrolled, randomized in two groups Figure 1: Flow chart of study participants
verum group and control group but no distinct similarities or 8. Pain in nape of neck, aggravation (agg.) looking upward
dissimilarities were found. or bending head backward
A comprehensive qualitative symptom profile of intervention 9. Pain and cramp in the extremities especially calf muscles
group, control group, and former homoeopathic proving 10. Complete sleeplessness in 6C and sleepiness in 30C
symptoms found in the literature [Table 4] reflect that: potency.
• Symptoms were generated in intervention group and The incidence of pathogenetic effects in this study has been
were placed in regional spheres (following the Schema found to be 1.35.
Repertory of the Homoeopathic Materia Medica by
J. T. Kent[12]) of Mind, Vertigo, Head, Eyes, Nose, Mouth, Placebo symptoms developed during the trial are placed in
Throat, Abdomen, Rectum, Cough, Back, Extremities, Table 5.
Sleep and Skin in the present study and were found to
have striking similarities to the symptoms present in the
homoeopathic literature[3,13,14]
Discussion
• In addition to the above, symptoms were also generated in In the present study, when the symptoms generated in
intervention group in regional spheres of teeth, stomach, the verum group, placebo group and the earlier proving
fever, and generalities. symptoms available in the homoeopathic literature were
compared, it was found that marked mental symptoms were
A brief summarization of the main symptoms observed which
elicited in this proving and many symptoms were similar to
are also mentioned in the homoeopathic literature is as follows:
1. Anger and attacks of rage those mentioned in the literature. Characteristic symptoms
2. Violent pain in the frontal region of the head were produced related to head, eye, mouth, abdomen,
3. Eyelids swollen rectum, cough, back and extremities, sleep and fever with
4. Dryness of mouth with thirst for cold water marked modalities, and associated symptoms. Well‑defined
5. Sore throat skin symptoms with finer details were observed in
6. Colicky, gripping pain in the abdomen and diarrhea comparison with a few vague symptoms mentioned in the
7. Dry cough with tearing/throbbing pain in the head homeopathic literature.
Table 4: Qualitative symptom profiles of intervention group, control group, and former Homoeopathic drug proving
symptoms
Section Placebo (C) Cuprum Cuprum aceticum Common symptoms Profile of cuprum
aceticum 6C 30C of verum and aceticum by previous
placebo groups homoeopathic provings
Mind Loquacity (talking Anger with irritability Extreme anguish[13]
about irrelevant when contradicted, Attacks of rage[3]
things), didn’t amelioration Talks all the time[3]
want to be being alone. This
Disconnected, delirious
interrupted, if is associated
talking[3]
interrupted feels with thoughts of
like hitting committing suicide
Loquacity (talking
about irrelevant
things), did not want
to be interrupted, if
interrupted feels like
hitting
Vertigo Vertigo with heaviness of head Vertigo, Vertigo Vertigo[3]
Vertigo with malaise and aggravation Vertigo, marked
low BP‑110/60 mm Hg; afternoon, and persistent, with
aggravation evening, lying amelioration stupefaction[14]
down and next day BP‑110/50 evening
mm Hg; aggravation evening
Vertigo with dizziness and
drowsiness; amelioration lying
down
Head Heaviness in head; Bursting pain in Bursting pain in Dull aching pain in Headache in nearly all
aggravation evening, frontal region of head; aggravation frontal region of head cases. Very violent,
amelioration rest head; aggravation night, amelioration especially in the forehead
Dull aching pain in frontal night pressure and vertex, becoming
region of head with Pain in head as Pain in head with less after 1 or 2 days,
drowsiness and vertigo; if head would feeling as if head sometimes however
aggravation 3 pm to 5 pm, burst (10 am would burst in small returning[3]
amelioration placing hand to 12 noon); pieces associated Sensation of pressure and
on forehead. Next day same aggravation with sleepiness; heaviness in the head[3]
symptom persisted for whole stooping aggravation bending Throbbing pain in whole
day Dull, aching forward head. Beating headache.
Aching pain in frontal and pain in frontal Bursting pain in Violent headache[3]
supra‑orbital region of region of head frontal region of Violent pain in the frontal
head; aggravation motion, with coryza; head; aggravation region. Violent pains in
amelioration pressure aggravation walking, noise, the forehead[3]
Bursting pain at vertex walking, amelioration tight
extending to frontal region; bending forward, bandaging
aggravation night. Next day afternoon
onwards associated with till night,
sleepiness amelioration
Heaviness in occipital region pressure, after
of head (10 am to 6 pm). sleep
Next day aching pain in head.
Heaviness in the occipital
region of the head reappeared
after 4 days and continued for
3 days
Heaviness of the head
Aching pain in the frontal
region of the head extending
to vertex; aggravation after
waking. This was associated
with vomiting (two episodes)
on the 2nd day
Contd...
Table 4: Contd...
Section Placebo (C) Cuprum Cuprum aceticum Common symptoms Profile of cuprum
aceticum 6C 30C of verum and aceticum by previous
placebo groups homoeopathic provings
Aching pain in whole head
with vertigo, sleeplessness
and nausea (9 am to 12 noon);
amelioration by pressing
Aching pain in left side of
head associated with heaviness
of whole head and over
eyebrows (12 noon to 4 pm);
amelioration by pressing, after
sleep
Aching pain in occipital
region of head; aggravation
moving head in lying position,
amelioration drinking tea
Bursting pain in occipital
region radiating to eyeballs;
aggravation pressure, night
Pain in bi‑temporal region
with sensation of heaviness;
aggravation opening eyes,
talking, amelioration closing
eyes
Left sided headache at 2: 30
pm for 2-3 min
Eye Swelling of both lower eye Swelling of both Heaviness in both Swelling of both Eyelids very red and
lids for 2 days. After a gap of lower eyelids; eyes followed by lower eyelids swollen, so that they
1 day felt heaviness in eyes as aggravation retro‑orbital pain could hardly be opened[3]
if swollen which persisted for morning with burning in eyes;
4 days aggravation after
studying. Next day
lachrymation in both
eyes with itching and
puffiness around the
eyes; aggravation
after studying
Nose Sneezing (5-6 bouts) with Sneezing with Coryza with watery Sneezing with watery Very violent fluent
watery nasal discharge and watery nasal nasal discharge; nasal discharge coryza, with lachrymation
lachrymation associated with discharge; aggravation morning, and smarting in the eyes[3]
retro‑orbital pain aggravation night
Watery nasal discharge with morning
sneezing
Coryza with watery nasal
discharge and sneezing;
aggravation morning, cold
air, amelioration afternoon,
evening
Watery nasal discharge with
right‑sided frontal headache at
5 pm for 5 min
Face Red‑colored papule on right
cheek with throbbing pain
Contd...
Table 4: Contd...
Section Placebo (C) Cuprum Cuprum aceticum Common symptoms Profile of cuprum
aceticum 6C 30C of verum and aceticum by previous
placebo groups homoeopathic provings
Mouth Burning sensation in the Aphthae on Dryness of the mouth[3]
mouth with red discoloration lower lip, white Great thirst for cold
of buccal mucosa and ulcer on in colour, with water[3]
edge and tip of tongue red margins, and
burning pain;
aggravation
eating, talking
Aphthae in mouth
with burning pain,
whitish in colour,
red in margin with
dry tongue
Dryness of mouth
with excessive
thirst and desire
for cold water
Teeth Stitching pain in Stitching pain in first
right lower molar; right lower molar
aggravation eating radiating to right
ear; aggravation cold
drink, amelioration
warm water
Throat Rawness in throat Sore throat A/F Sore throat Inflammation of the
Pain in throat (soreness with exposure to dust; throat, preventing
hoarseness) with general aggravation swallowing[3]
weakness, tiredness and noon to evening,
heat in palms and body; cold water,
aggravation on swallowing amelioration
Soreness in throat with dryness taking tea,
and difficulty in eating food gargling by hot
water
Soreness of throat with
tingling sensation
Soreness in throat with
excessive salivation and
difficulty in swallowing
Soreness in throat associated
with dryness of mouth
and malaise; aggravation
swallowing solid food
Stomach Vomiting of mucus in morning Nausea with Nausea
followed by nausea weakness;
Nausea for 2 days. Reappeared aggravation 9 am
after 7 days for 2 days
Heaviness in epigastric region
with nausea and bloating of
abdomen; aggravation evening
till mid night
Burning pain in epigastric
region, associated with nausea
and belching; aggravation
lying down, amelioration
after vomiting (thrice) of
undigested food
Nausea with sensation
of obstruction in throat;
aggravation after dinner
Vomiting of food eaten (twice
at 6:30 am and 6 pm) with
bleeding from left nostril;
aggravation after breakfast
Contd...
Table 4: Contd...
Section Placebo (C) Cuprum Cuprum aceticum Common symptoms Profile of cuprum
aceticum 6C 30C of verum and aceticum by previous
placebo groups homoeopathic provings
Abdomen Aching pain in abdomen Cutting pain Heaviness and Aching pain in Tearing‑cutting pain in
with heaviness; aggravation in abdomen; stinging pain in abdomen the abdomen[3]
morning aggravation eating whole abdomen; Cutting pain in Occasional griping pains
Aching pain in epigastric Aching pain in aggravation eating, abdomen in abdomen[3]
region with drowsiness; abdomen at 6 amelioration pressure Profuse diarrhoea; the
aggravation before and after pm (umbilical Heaviness in stools continues for a
eating region). Next day epigastric region long time with tenesmus
Cutting pain in epigastric pain increased Colicky pain and prostration, only
region aggravation 12 noon to in intensity with in abdomen; relieved after 8 days[3]
2 pm. Next day aching pain loose watery aggravation Pain in region of
in abdomen for same timings. stool (3-4 times/ eating, drinking, stomach[3]
After a gap of 1 day aching day); aggravation amelioration Violent colic in stomach
pain in abdomen reappeared eating pressure, bending and bowels[3]
and continued for 4 days Gripping pain forward
Aching pain in right in abdomen
hypochondrium with dark with loose
colored stool in morning; stool (3 times/
amelioration pressure. day), associated
Symptom continued whole with great thirst,
day but intensity of pain much loss of appetite,
reduced when woke up next and bitter taste
day and subsided after stool
Macular eruption with itching
on abdomen turned into boils
next day
Aching pain in right
hypochondrium; aggravation 9
am to 1 pm
Cutting pain in abdomen
associated with diminished
appetite and increased thirst
for cold water; aggravation
2 pm
Aching pain in lower
abdomen; aggravation lying
on back, amelioration lying on
abdomen
Aching pain in both
hypochondrium (6 pm to 9
pm)
Rectum Bleeding per rectum while Stool mixed Hard, unsatisfactory Bleeding per rectum Smarting at the anus after
passing soft stool with blood, stool stoo[3]
Fruity smell in stool (one burning sensation
episode) in rectum;
amelioration cold
application
Urine Profuse urination (without
reason)
Contd...
Table 4: Contd...
Section Placebo (C) Cuprum Cuprum aceticum Common symptoms Profile of cuprum
aceticum 6C 30C of verum and aceticum by previous
placebo groups homoeopathic provings
Cough Dry cough associated Dry cough; Dry cough with Dry cough Frequent, violent, dry
with running nose and aggravation night scanty, white cough, with tearing pain
fever (100°F); amelioration expectoration in the head; the cough
warm drinks. No fever for associated with was followed by violent
next 2 days but heat of body throbbing pain in pulsation of the heart,
present (URTI) head on coughing, lasting several min; at
Cough with mucoid heaviness in head this time the anxiety
expectoration associated with throughout the day and pressure in the chest
coryza and heaviness in chest; and fever (99.6°F). returned, especially while
aggravation morning, while But cough symptoms sitting; cough came on at
sleeping, amelioration warm continued for next night between 11 and 1[3]
drinks, warm room 2 days and fever
Dry cough with pain in again on the third
throat, nasal obstruction and day (99°F)
yellowish nasal discharge;
aggravation morning, daytime,
after eating, cold things
Chest Itching on sub‑mammary
region, scratching leads
to burning; amelioration
undressing
Back Stitching pain in lumbar Aching pain in Cutting pain in Pain in lumbar region Lancinating pain at the
region with restlessness, nape of neck lumbar region; nape of neck, on bending
extending towards from 2 pm to 7 aggravation lying head backwards[3]
right side; amelioration pm; aggravation down, walking, Pain in the loins[3]
massaging (temporary relief) looking upwards. amelioration sitting,
Next day the warmth
intensity of
symptom
increased from
morning till
evening and
continued for 2
more days
Dull aching pain
with stiffness in
lumbar region;
aggravation
afternoon till
night, walking,
lying down,
amelioration
massaging
Extremities Aching pain in lower Stitching pain in Stitching pain in Pain in lower Pain and cramp in the
extremities; aggravation night lower extremities calves; aggravation extremities extremities[3]
Stitching pain with stiffness especially walking, amelioration Violent cramping,
and difficulty in movement of calf muscles; pressure paroxysmal, in the
right shoulder (4 pm to 8 pm) aggravation night Stitching pain in both calves[3]
Tearing, bony pain in left Itching in right legs; aggravation Violent drawing and
forearm with inability to hold leg, scratching night, amelioration tension in limbs[14]
anything (8 am to 11 am) leads to burning pressure
Aching pain in right leg over
shin; aggravation walking for
10 days. This was associated
with numbness in both lower
extremities; aggravation sitting
for 5-10 min with folded legs
which lasted for 1 more day
Contd...
Table 4: Contd...
Section Placebo (C) Cuprum Cuprum aceticum Common symptoms Profile of cuprum
aceticum 6C 30C of verum and aceticum by previous
placebo groups homoeopathic provings
Sleep Sleeplessness Sleepiness Complete sleeplessness,
lasting 5 days frequently lasting three or
4 days[3]
Great sleepiness[3]
Fever Fever (101°F) with chills Fever with chills Fever (102°F) Fever with chills and
associated with sore throat and body ache associated with fever with bodyache
and watery discharge from in the evening; vomiting (once of
nose; amelioration warm aggravation cold undigested food
application, warm drinks, weather particles), vertigo,
gargles. On 3rd day only restlessness,
watery nasal discharge weakness, reduced
Fever (99.8°F) with body ache appetite and disturbed
and malaise sleep during day and
Fever with bodyache, nausea night
and dizziness started in
evening and persisted till
morning
Skin Itching followed by redness Small red macules Eruptions with Eruptions on the skin[3]
and eruptions (wheal on the left side itching
formation) on whole body of the neck and
associated with sleepiness shoulder without
on and off whole night; itching for 8 days.
aggravation after taking bath. Then only on
Itching reappeared around 1 neck since the
pm with small red eruptions 9th day and
on the hands. Same symptoms disappeared after
reappeared at 10 pm with 5 days
sleepiness and continued till Small, red papular
2 days eruptions on
Eruptions with itching on the right arm
lateral side of both elbows; and front of the
aggravation 4 pm and 8 pm, neck, associated
amelioration morning with itching
Itching whole body and burning;
Itching on lateral sides of both aggravation
arms just below shoulders touch, night,
aggravation 9 to 9:30 pm for amelioration
3 days. On 4th day eruptions rubbing
also appeared at the same site
with itching which are hard
to touch. On the 11th day,
skin become hyperpigmented
on the spot of eruption while
itching continued, then turned
into wheal with occasional
bleeding on scratching
Itching all over body with
macular eruptions which are
red in colour
Itching with macular eruptions
on lateral side of left arm just
below the shoulder. Next day
wheal formation; aggravation
after undressing (9 pm to 1
am). On 4th day only itching
remained
Contd...
Table 4: Contd...
Section Placebo (C) Cuprum Cuprum aceticum Common symptoms Profile of cuprum
aceticum 6C 30C of verum and aceticum by previous
placebo groups homoeopathic provings
Generalities Weakness and does not Weakness of Weakness of whole
want to talk to anyone. After whole body body
2 days interval weakness of associated with
whole body reappeared with vertigo
sensation of fatigue, malaise, Burning sensation
wants to lie down and does not in whole body
want to talk to anyone
General weakness and
tiredness of whole body;
aggravation evening
Weakness
Weakness with fatigue and
malaise with low BP (110/50
mm Hg). Next day BP=90/60
mm Hg
URTI: Upper respiratory tract infection, BP: Blood pressure
Contd...
Table 5: Contd...
Each one of these symptoms mentioned below were developed and reported by single prover
Location Symptoms observed Doses Symptom duration in days
Mouth Burning sensation in the mouth with red discoloration of buccal mucosa and ulcer on edge 11 4 days
and tip of tongue. Dryness of mouth
Face Red coloured papule on right cheek with throbbing pain 8 15 days
Throat Rawness in throat 6 6 days
Pain in throat (soreness with hoarseness) with general weakness, tiredness and heat in 6 4 days
palms and body; aggravation on swallowing
Soreness in throat with dryness and difficulty in eating food 6 1 day
Soreness of throat with tingling sensation 4 5 days
Soreness in throat with excessive salivation and difficulty in swallowing 11 4 days
Soreness in throat associated with dryness of mouth and malaise; aggravation swallowing 7 3 days
solid food
Stomach Vomiting of mucus in morning followed by nausea 8 2 days
Nausea for 2 days. Reappeared after 7 days for 2 days 8 4 days
Heaviness in epigastric region with nausea and bloating of abdomen; aggravation evening 4 1 day
till mid night
Burning pain in epigastric region, associated with nausea and belching; aggravation lying 12 1 day
down, amelioration after vomiting (thrice) of undigested food
Nausea with sensation of obstruction in throat; aggravation after dinner 4 2 days
Vomiting of food eaten (twice at 6:30 am and 6 pm) with bleeding from left nostril; 4 1 day
aggravation after breakfast
Abdomen Aching pain in abdomen with heaviness; aggravation morning 12 3h
Aching pain in epigastric region with drowsiness; aggravation before and after eating 6 2 days
Cutting pain in epigastric region aggravation 12 noon to 2 pm. Next day aching pain in 8 6 days
abdomen for same timings. After a gap of 1 day aching pain in abdomen reappeared and
continued for 4 days
Aching pain in right hypochondrium with dark colored stool in morning; amelioration 12 2 days
pressure. Symptom continued whole day but intensity of pain much reduced after waking
up next day and subsided after stool
Macular eruption with itching on abdomen turned into boils next day 5 2 days
Aching pain in right hypochondrium; aggravation 9 am to 1 pm 5 4h
Cutting pain in abdomen associated with diminished appetite and increased thirst for cold 8 3 days
water; aggravation 2 pm
Aching pain in lower abdomen; aggravation lying on back, amelioration lying on abdomen 4 3 days
Aching pain in both hypochondrium (6 pm to 9 pm) 7 3h
Rectum Bleeding per rectum while passing soft stool 4 2 days
Stool Fruity smell in stool (one episode) 5 1 day
Urine Profuse urination (without reason) 4 30 days
Cough Dry cough associated with running nose and fever (100°F); amelioration warm drinks. No 12 3 days
fever for next 2 days but heat of body present (URTI)
Cough with mucoid expectoration associated with coryza and heaviness in chest; 4 3 days
aggravation morning, while sleeping, amelioration warm drinks, warm room
Dry cough with pain in throat, nasal obstruction and yellowish nasal discharge; aggravation 3 5 days
morning, daytime, after eating, cold things
Chest Itching on sub‑mammary region, scratching leads to burning; amelioration undressing 4 6 days
Back Stitching pain in the lumbar region with restlessness, extending toward right side; 8 4 days
amelioration massaging (temporary relief)
Extremities Aching pain in lower extremities; aggravation night 8 4 days
Stitching pain with stiffness and difficulty in the movement of the right shoulder (4 pm to 6 4h
8 pm)
Tearing, bony pain in the left forearm with inability to hold anything. (8 am to 11 am) 3 3h
Aching pain in the right leg over shin; aggravation walking for 10 days. This was 8 11 days
associated with numbness in both lower extremities; aggravation sitting for 5-10 min with
folded legs which lasted for 1 more day
Contd...
Table 5: Contd...
Each one of these symptoms mentioned below were developed and reported by single prover
Location Symptoms observed Doses Symptom duration in days
Fever Fever (101◦ F) with chills associated with sore throat and watery discharge from nose; 12 3 days
amelioration warm application, warm drinks, gargles. On the 3rd day, only watery nasal
discharge
Fever (99.8°F) with body ache and malaise 10 4 days
Fever with body ache, nausea, and dizziness started in the evening and persisted till the 11 1 day
morning.
Skin Itching followed by redness and eruptions (wheal formation) on whole body associated 12 4 days
with sleepiness on and off whole night; aggravation after taking bath. Itching reappeared
around 1 pm with small red eruptions on the hands. Same symptoms reappeared at 10 pm
with sleepiness and continued till 2 days
Eruptions with itching on lateral side of both elbows; aggravation 4 pm and 8 pm, 12 5 days
amelioration morning
Itching whole body 5 6 days
Itching on the lateral sides of both arms just below shoulders aggravation 9 to 9:30 pm 12 15 days
for 3 days. On the 4th day, eruptions also appeared at the same site with itching which are
hard to touch. On the 11th day, skin become hyperpigmented on the spot of eruption while
itching continued, then turned into wheal with occasional bleeding on scratching
Itching all over the body with macular eruption which are red in color 7 12 days
Itching with macular eruption on the lateral side of the left arm just below the shoulder. 12 4 days
Next day wheal formation; aggravation after undressing (9 pm to 1 am). On the 4th day,
only itching remained
Generalities Weakness and does not want to talk to anyone. After 2 days interval weakness of whole 8 3 days
body reappeared with sensation of fatigue, malaise, wants to lie down, and does not want to
talk to anyone
General weakness and tiredness of whole body; aggravation evening 3 4h
Weakness 8 1 day
Weakness with fatigue and malaise with low BP (110/50 mm Hg). Next day BP=90/60 8 4 days
mm Hg
URTI: Upper respiratory tract infection, BP: Blood pressure
Certain symptoms developed during the proving trial were this can be attributed to the discussion which usually takes
quite similar to those found in previous literature. Thus, it place among the students of homoeopathic colleges who are
can be considered as a characteristic for this drug. However, the participants in the study. This poses a limitation as it is
there have been additional findings as well in a few of difficult to keep a check on them for not discussing or sharing
these symptoms which need to be clinically verified. A few the experiences. The massive number of symptoms developed
symptoms which are overlapping in both the groups could be in the control group could be considered because of such
due to the nocebo effect or due to confounding factors such discussions among the students.
as alteration in weather, food or regimen. Although adequate
efforts were made to rule out such effects by proper record There are certain other limitations in the study apart from the
keeping, these can’t be ruled out completely. The pathogenetic nocebo effect; like no defined parameters for the classification
findings of this drug need further verification by using it for of characteristic symptoms and less number of provers which
therapeutic purposes in the patients reporting with similar may be addressed in future studies.
symptoms.
In one of the articles, Dr. Teut[15] has mentioned that ‘placebo Conclusion
proving occasionally seem to produce similar symptoms The pathogenesis of the Cu acet. found in this study has
to the proving symptoms, thus casting further doubt on produced symptoms which were already noted in the
the use of this medium in proving’ and has attributed it to homoeopathic literature and there are many symptoms which
nocebo effect. A nocebo response is explained as subject’s are new. These signs and symptoms need to be subjected to
own negative expectations and/or negative suggestions clinical verification study for confirming their therapeutic
from therapists/clinical staff in the absence of any treatment. utility. This will further enhance the scope and utility of this
Nocebo phenomena are generally explained by Pavlovian drug by the profession.
conditioning and expectations induced by verbal information
and suggestions. In this trial also nocebo phenomenon can be Financial support and sponsorship
considered and apart from the individual’s own perception, Nil.
D;wIje ,lsfVde dk gksE;ksiSfFkd jksxtud iSFkkstsusfVd ijh{k.k% ,d cgqdsfUnzd] Mcy - & CykbaM ;kn`fPNd] Iykflcks fu;af=r ijh{k.k
i`‘BHkwfe% ;|fi D;wIje esVsfyde dk y{k.k foKku csgn foLr`r gS] blds vU; {kkj viw.kZ :i ls fl) gSaA vr%] D;wIje ,lsfVde ds fy,
gksE;ksiSfFkd jksxtud iSFkkstsusfVd ijh{k.k fd;k x;k FkkA mn~ns”;% LoLFk euq”; izwolZ ij gksE;ksiSfFkd izHkkoksa esa D;wIje ,lsfVde ds izfr
iSFkstsusfVd izfrfØ;k dk lkj fudkyukA lkefxz;k¡ ,oa i)fr;k¡% dsUnzh; gksE;ksiSfFkd vuqla/kku laLFkku ¼lhlhvkj,p½ ds rhu dsUnzksa ij ,d
cgq&dsfUnzd Mcy& CykbaM ;kn`fPNd] Iykflcks fu;af=r]ijh{k.k lapkfyr fd;k x;k FkkA iwoZ&ijh{k.k fpfdRlh; tk¡p dks lapkfyr djus ds
i’pkr~ pqus x, 50 lacaf/kr LoLFk izwolZ ij izwfoax v/;;u lapkfyr fd;k x;kA lHkh izwolZ dks ijh{k.k ds izFke pj.k ds nkSjku Iykflcks nh xbZ
FkhA vxys nks pj.kksa esa] ;kn`fPNdhdj.k ds i’pkr~] D;wIje ,lsfVde dks gLr{ksih; lewg esa ¼,u ¾ 34½] rFkk Iykflcks lewg esa ¼,u ¾ 16½ 60
lh ,oa 30 lh izHkkoksa esa O;ofLFkr fd;k x;k FkkA D;wIje ,lsfVde ls mikftZr izHkkfor vkadM+ksa dks v/;;u &lg&vk¡dM+k izØe.k izdks"B esa
ladfyr ,oa ewY;kafdr fd;k x;k FkkA ifj.kke% 34 izwolZ esa ls tks okLrfod nok ijh{k.k ij Fks] dsoy 12 izwolZ us gh y{k.kksa dks O;Dr fd;k FkkA
30 lh ,oa 200lh izHkko'khyrk esa Øe'k% 26 ,oa 20 y{k.k O;Dr fd, x, FksA fu"d"kZ% v/;;u ijh{k.k ds nkSjku izkIr gqbZ iSFkkstsusfVd izfrfØ;k
us D;wIje ,lsfVde gksE;ksiSfFkd nok ds bLrseky dh laHkkouk dks c<+k fn;k gSA bl ijh{k.k esa mikftZr y{k.kksa dh cgqewY;rk uSnkfud lR;kiu
djus ij vkSj T;knk c<+sxhA
Ensayo patogenético homeopático de Cuprum aceticum: Ensayo multicéntrico, doble ciego, aleatorizado, controlado
con placebo
Fundamento: Aunque la sintomatología de Cuprum metallicum es bastante extensa, sus otras sales tienen pruebas fragmentarias.
Así, se realizó un ensayo patogenético homoeopático para Cuprum aceticum. Objetivo: Para obtener la respuesta patogénica
a Cuprum aceticum en potencias homeopáticas en demostradores humanos sanos. Materiales y métodos: Se llevó a cabo un
ensayo multicéntrico doble ciego aleatorizado, controlado con placebo, en tres centros del Consejo Central para la Investigación
en Homeopatía (CCRH). Se realizaron pruebas en 50 probadores relativamente sanos seleccionados después de realizar el
examen médico previo al ensayo. Todos los probadores recibieron placebo durante la primera fase del ensayo. En las dos fases
siguientes, Cuprum aceticum se administró en potencias 6C y 30C, en el grupo intervención (n=34); y placebo en el grupo
placebo (n=16), después de la aleatorización. Los datos de prueba así generados en Cuprum aceticum fueron compilados y
analizados en la celda de procesamiento de pruebas y datos. Resultado: De 34 probadores que estaban en ensayo real de
la droga, solamente 12 probadores manifestaron síntomas. 26 y 20 síntomas fueron manifestados en potencia 30C y 200C
respectivamente. Conclusión: La respuesta patogenética que se produjo durante el ensayo clínico de prueba amplía el alcance
del uso de la medicina homeopática Cuprum aceticum. Los síntomas generados en este ensayo tendrán más valor cuando se
verificen clínicamente.
醋酸铜的顺势病理实验:多中心、双盲、随机、安慰剂对照试验
背景:虽然铜金属的症状是相当庞大的,它的其他盐有零碎的证明。 因此,采取了铜针的顺势疗法的致病性试验。
目的:探讨顺势疗法对健康人的病理反应。 材料和方法:在顺势疗法研究委员会(CCRH)的三个中心进行了一项
多中心双盲随机安慰剂对照试验。 在进行审前体检后选择的50名相对健康的证明者上进行了证明。 在试验的第一阶
段,所有证明者都给予安慰剂。 在接下来的两个阶段, 在干预组(n=34) 分别以6C和30C的剂量给药;和安慰剂组(n=16)
。在验证实验数据处理单元上,对由此产生的丙酮铜的验证数据进行编辑和分析。结果:34名实际药物试验者中,
只有12人出现症状。30C和200C的药力分别表现出26和20种症状。结论:在验证试验中引发的病理反应扩大了同种顺
势疗法药物醋酸铜的应用范围。临床验证时,此试验产生的症状将更有价值。